Revolutionizing Medicine: The Evolving Landscape of Cell & Gene Therapy in the US

Revolutionizing Medicine: The Evolving Landscape of Cell & Gene Therapy in the US

Tuesday, June 2, 2026 4:15 PM to 4:55 PM · 40 min. (America/New_York)
Main Stage
Track 2 - R&D Excellence – Biologics
Drug Formulation and DevelopmentMarket InsightsR&D ExcellenceRegulation & PolicySupply Chain Management and Dynamics

Information

This session explores the dynamic US cell and gene therapy market, projected to surge from USD 7 billion in 2025 to over USD 50 billion by 2034 at a 23% CAGR, driven by breakthroughs in personalized medicine (Deloitte, McKinsey). Delve into recent FDA regulatory shifts, including approvals such as Itvisma for SMA and Waskyra for rare WAS, and new draft guidances enabling flexible manufacturing and accelerated pathways for rare diseases. Attendees will uncover key manufacturing hurdles, such as scalability and automation needs amid a $26 billion manufacturing sector expanding at 26% annually, alongside innovative commercial strategies to enhance access. Gain forward-looking perspectives on non-oncology growth, in vivo editing, and global competition, equipping you to seize opportunities in this transformative field and drive strategic advancements in advanced therapeutics.